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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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Diss Factsheets

Administrative data

Description of key information

The test material produced a primary irritation index of 0.0 and was classified as non-irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.

The test material caused no corneal or iridal effects in rabbit eyes. Conjunctivae showd an overal mean irritation score of 0.75 during 72 hours.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1991
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
1981
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
The animals were individually housed in suspended metal cages.
Free access to mains drinking water and food (Spillers Rabbit Diet,
Dalgety Agriculture Ltd., Almondsbury, Bristol) was allowed
throughout the study.
The animal room was maintained at a temperature of 18 - 22•c and
relative humidity of 55 - 64%. The rate of air exchange was
approximately 15 changes per hour and the lighting was controlled
by a time switch to give continuous 12 hours light and 12 hours
darkness.
Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
water
Controls:
not required
Amount / concentration applied:
500 mg/site moistened with an equal amount of Water
Duration of treatment / exposure:
4 h
Observation period:
72 h
Number of animals:
3
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
8
Reversibility:
other: not applicable
Remarks:
faint coloration by the test material was seen in 2 animals
Remarks on result:
no indication of irritation
Interpretation of results:
GHS criteria not met
Conclusions:
The test material, produced a primary irritation index of 0.0 and was classified as NON-IRRITANT to rabbit skin according to the Draize classification scheme. No corrosive effects were noted .
Executive summary:

A study was performed to assess the irritancy potential of the test material to the skin of the New Zealand White rabbit. The method used follwed that described in the OECD Guidelines for Testing of Chemicals (1981) No. 404 "Acute Dermal Irritation/Corrosion" referenced as Method B4 in

Commission Directive 84/449/EEC (which constitutes Annex V of Council Directive 67/548/EEC).

A single 4-hour, semi-occluded application of the test material to the intact skin of three rabbits produced very slight erythema at two treated skin sites one hour after patch removal.

The test material produced a primary irritation index of 0.0 and was classified as non-irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.

The test material was also classified as non-irritant according to EEC labelling regulations.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
0ECD Guidelines for Testing of Chemicals (1987) No. 405 "Acute Eye Imitation/Corrosion" referenced as Method B5 in Comrnission Directive 84/449/EEC (which constitutes Annex V of Council Di recti ve 67 /548/EEC.
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Species:
rabbit
Strain:
New Zealand White
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
100 mg/animal; undiluted
Duration of treatment / exposure:
no washing
Observation period (in vivo):
72 h
Number of animals or in vitro replicates:
3
Details on study design:
one rabbit was initially treated. The test material (100 mg) was placed into the coniunctival sac of the right eye, formed by gently pulling the lower Iid away from the eyeball. The upper and lower eyelids were held together for about one second irunediately after application, to prevent loss of the test material, and then released. The left eye remained untreated and was used for control purposes. Irmediately after administration of the test material, an assessment of the initial pain reaction was made.
After consideration of the ocular responses produced in the first treated animal, two additional animals were treated.
Assessment of ocular damage/iwitation was made approximately I hour and 24, 48 and 72 hours following treatment, according to the numerical evaluation given in Appendix I, (from Draize J.H. 1959, Association of Food and Drug Officials of the United States, Austin, Texas, "The Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics").
Any other adverse ocular effects were also noted. Examination of the eye was faciIitated by use of the Iight source from a standard ophthalmoscope.
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48 h
Score:
ca. 0.75
Reversibility:
fully reversible within: 72 h
Remarks on result:
probability of weak irritation
Interpretation of results:
GHS criteria not met
Conclusions:
The test material, produced a maximum group mean score of 0.75 and was a weak irritant to the rabbit conjunctivae.
Executive summary:

A study was performed to assess the irritancy potential of the test material to the eye of the New Zealand Wlhite rabbit. The method used

followed that described in the 0ECD Guidelines for Testing of Chemicals (1987) No. 405 "Acute Eye Imitation/Corrosion" referenced as Method B5

in Conrnission Directive 84/449/EEC (which constitutes Annex V of Council Directi ve 67 /548/EEC)

A single application of the test material to the non-irrigated eye of three rabbits produced moderate coniunctival irritation. Neither corneal nor iridal effects were seen. All treated eyes appeared normal 72 hours after treatment

The test material produced a maximum group mean score of 0.75 and was classified as a mild irritant (Class 4 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system.

The test material was also classified as non-irritant according to EEC labelling regulations.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

No classification

The test material was not irritant on rabbit skin as well as rabbit eyes.